510(k) Report

Devices descending from K103490

20 later devices reach Expedium Spine System, Moss Miami Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K160820PressON Pro Spinal Fixation SystemNexus Spine, LLC20160—
+1K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+1K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+1K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+1K122229Viceroy Spinal SystemTorrey Spine20120—
+1K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+1K120091R&D Innovation Pedicle Screw SystemR&D Innovation, LLC20121—
+1K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+2K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+2K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+2K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+2K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+3K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—